Yentreve

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Yentreve on Prescriptsy

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Yentreve is a brand of duloxetine, a serotonin and noradrenaline reuptake inhibitor (SNRI), available as 20 mg and 40 mg gastro-resistant capsules.

It is licensed specifically for the treatment of moderate to severe stress urinary incontinence (SUI) in women.

Yentreve works by increasing the activity of the pudendal nerve motor neurons that control the external urethral sphincter and pelvic floor muscles, improving urethral closure pressure during physical activities that cause urine leakage.

It is a prescription-only medicine (POM) in the United Kingdom.

Stress urinary incontinence is the most common type of urinary incontinence in women, affecting an estimated 1 in 3 women over 18 years of age in the UK.

It is defined as the involuntary leakage of urine on effort or exertion, or on sneezing or coughing (International Continence Society definition).

Despite its high prevalence, many women do not seek help due to embarrassment, with studies suggesting that only 1 in 4 affected women consult a healthcare professional.

SUI has a substantial impact on quality of life, physical activity, social participation, psychological wellbeing, and sexual function.

This page provides a comprehensive clinical guide to Yentreve, covering its mechanism of action, dosage, side effects, safety warnings, and how to obtain it in the United Kingdom.

Important safety information about Yentreve

Before reading further, note these essential safety points about Yentreve.

• Yentreve must not be taken with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping an MAOI.
• Do not stop Yentreve abruptly. Taper the dose gradually over 1 to 2 weeks to avoid discontinuation symptoms.
• Nausea is common initially but usually resolves within 1 to 4 weeks. Starting at a lower dose reduces this risk.
• Report any unexplained abdominal pain, dark urine, or jaundice immediately (signs of liver injury).
• Yentreve may cause dizziness and drowsiness. Do not drive until you know how it affects you.

Understanding stress urinary incontinence

Stress urinary incontinence occurs when the urethral closure mechanism fails to maintain a seal during activities that increase intra-abdominal pressure.

The continence mechanism depends on the structural support of the urethra and bladder neck by the pelvic floor muscles (levator ani, particularly the pubococcygeus), the endopelvic fascia, and the ligamentous attachments (pubourethral and uterosacral ligaments), as well as the intrinsic closure function of the urethral sphincter itself (smooth muscle, striated muscle, mucosal coaptation, and vascular cushion).

SUI develops when these support structures are weakened or damaged.

The most common risk factors include vaginal childbirth (particularly prolonged labour, forceps delivery, large birth weight, and multiple deliveries), which causes direct injury to the pelvic floor muscles, pudendal nerve, and fascial supports.

Ageing and postmenopausal oestrogen decline lead to atrophy of urethral mucosa and reduced urethral closure pressure. Obesity increases intra-abdominal pressure chronically.

Chronic cough (for example from COPD or smoking), chronic constipation, heavy lifting, and high-impact exercise are additional contributing factors.

Pelvic surgery (particularly hysterectomy) and connective tissue disorders also increase risk.

Urinary incontinence is classified into three main types: stress urinary incontinence (leakage with physical effort), urgency urinary incontinence (leakage associated with a sudden compelling desire to void, as in overactive bladder), and mixed urinary incontinence (both stress and urgency components).

Accurate diagnosis is important because the management approach differs.

SUI is primarily managed with pelvic floor muscle training, with duloxetine as a pharmacological adjunct, and surgical options (mid-urethral sling, colposuspension) for those who do not respond to conservative measures.

How Yentreve works

Duloxetine increases serotonin (5-HT) and noradrenaline (NA) concentrations in the synaptic cleft of the pudendal motor neurons in Onuf's nucleus (sacral spinal cord segments S2 to S4).

These motor neurons innervate the external urethral sphincter (rhabdosphincter) and the levator ani muscles of the pelvic floor.

During the storage phase of the bladder cycle, glutamatergic excitatory inputs from the pontine storage centre activate these motor neurons, and serotonin and noradrenaline amplify this excitatory signal.

By inhibiting the reuptake of both neurotransmitters, duloxetine enhances the tonic firing rate of the pudendal motor neurons, increasing urethral striated muscle contraction force and urethral closure pressure.

This effect is demonstrated by urodynamic studies showing that duloxetine increases maximum urethral closure pressure by approximately 10 to 20 cmH2O during the filling phase, without affecting detrusor (bladder muscle) function or voiding efficiency.

The mechanism is specific to the storage phase: duloxetine does not impair normal voluntary voiding because voiding is mediated by a separate parasympathetic (muscarinic) pathway and simultaneous relaxation of the sphincter via inhibition of pudendal nerve activity.

Duloxetine is rapidly absorbed after oral administration, reaching peak plasma concentrations in approximately 6 hours. The gastro-resistant formulation avoids degradation in the stomach. Bioavailability is approximately 50%.

It is extensively bound to plasma proteins (96%, primarily albumin and alpha-1 acid glycoprotein) and is metabolised by hepatic CYP1A2 and CYP2D6 to inactive metabolites.

The elimination half-life is approximately 12 hours, supporting twice-daily dosing. Renal excretion of unchanged drug accounts for less than 1% of the dose.

Clinical evidence for Yentreve in stress urinary incontinence

The efficacy of duloxetine for SUI was established in 4 pivotal randomised, double-blind, placebo-controlled trials involving over 1,900 women with predominantly stress urinary incontinence.

In these trials, duloxetine 40 mg twice daily reduced the median number of incontinence episodes per week by 50 to 60% compared with 30 to 40% with placebo (a statistically significant difference).

The Incontinence Quality of Life (I-QoL) questionnaire scores improved significantly more with duloxetine than with placebo.

Approximately 50% of duloxetine-treated women achieved a 50% or greater reduction in incontinence episodes.

NICE guideline NG123 on urinary incontinence and pelvic organ prolapse recommends duloxetine as a second-line pharmacological option for women with SUI who prefer pharmacological treatment over surgery, or as a temporary measure while awaiting surgery, or as an adjunct to pelvic floor muscle training.

NICE notes that duloxetine should not be offered as first-line treatment for SUI, as supervised pelvic floor muscle training for at least 3 months is the recommended first-line intervention.

The combination of pelvic floor exercises and duloxetine provides greater improvement than either alone.

Dosage and administration

Start at 20 mg twice daily for the first 2 weeks to reduce the incidence of nausea.

Increase to the maintenance dose of 40 mg twice daily from week 3. Swallow capsules whole with water. Do not open, crush, or chew.

May be taken with or without food.

Assess clinical response after 2 to 4 weeks at the full dose.

If no meaningful improvement in incontinence episodes is achieved, discuss the limited benefit of continuing and consider discontinuation.

Women who respond well may continue treatment long-term, although the optimal duration has not been established. Periodic reassessment of the need for continued treatment is recommended.

When discontinuing, taper over 1 to 2 weeks: reduce to 20 mg twice daily for 2 weeks before stopping. This minimises discontinuation symptoms.

Side effects of Yentreve

Common side effects

Nausea affects approximately 23% of women (versus 4% with placebo) and is the most common reason for discontinuation (approximately 4.5% of women in clinical trials discontinued due to nausea).

It typically starts within the first 3 days, peaks in the first week, and resolves within 1 to 4 weeks.

Starting at 20 mg twice daily for 2 weeks reduces the incidence by approximately 50%.

Dry mouth, headache, constipation, dizziness, insomnia, drowsiness, fatigue, decreased appetite, and increased sweating are each reported in 1 to 10% of women.

Uncommon and rare side effects

Palpitations, tremor, blurred vision, sexual dysfunction, weight changes, urinary hesitancy, and tinnitus are uncommon. Serotonin syndrome is rare but potentially life-threatening.

Hepatotoxicity (raised liver enzymes, hepatitis, and very rarely hepatic failure) has been reported. Severe skin reactions (Stevens-Johnson syndrome, erythema multiforme) are very rare.

Hyponatraemia occurs rarely, primarily in elderly patients and those taking diuretics.

Suicidal ideation has been reported with SNRIs generally, though the SUI population is predominantly older women at lower risk.

Discontinuation symptoms

Abrupt cessation after regular use can cause dizziness, nausea, headache, paraesthesia (tingling sensations), irritability, anxiety, insomnia, nightmares, diarrhoea, and electric shock-like sensations.

These typically start within 1 to 4 days of stopping and resolve within 1 to 2 weeks.

Gradual dose reduction over 1 to 2 weeks is recommended to minimise these effects. Report suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk .

Warnings and precautions

Contraindications

Yentreve is contraindicated in hepatic impairment (any degree), severe renal impairment (creatinine clearance below 30 mL/min), uncontrolled hypertension, concurrent or recent (within 14 days) MAOI use, and concurrent use with potent CYP1A2 inhibitors (fluvoxamine, ciprofloxacin).

Hypersensitivity to duloxetine or any excipient is also a contraindication.

Drug interactions

MAOIs: contraindicated due to risk of serotonin syndrome. Other serotonergic drugs (SSRIs, SNRIs, triptans, tramadol, pethidine, lithium, St John's wort): increased risk of serotonin syndrome; use with caution.

CYP1A2 inhibitors (fluvoxamine, ciprofloxacin): significantly increase duloxetine levels; contraindicated. CYP2D6 inhibitors (paroxetine, fluoxetine, quinidine): increase duloxetine exposure; use with caution.

CYP2D6 substrates (tricyclic antidepressants, metoprolol, codeine): duloxetine is a moderate CYP2D6 inhibitor and may increase levels of these drugs. Warfarin: increased INR has been reported; monitor closely.

Smoking: induces CYP1A2, reducing duloxetine levels by approximately 50%.

Special populations

Hepatic impairment: contraindicated at any degree of impairment. Duloxetine is extensively hepatically metabolised, and exposure increases substantially in liver disease.

Renal impairment: mild to moderate (creatinine clearance 30 mL/min or above) requires no dose adjustment; severe impairment (below 30 mL/min) is contraindicated due to significantly increased exposure.

Elderly: use with caution; increased risk of hyponatraemia and falls due to dizziness. Pregnancy: avoid unless clearly necessary; neonatal withdrawal symptoms reported with third-trimester use.

Breastfeeding: duloxetine is excreted in breast milk; not recommended.

How to get Yentreve in the UK

Yentreve is available on NHS prescription from your GP or specialist (urologist, urogynaecologist, or continence specialist).

It is usually considered after an adequate trial (at least 3 months) of supervised pelvic floor muscle training has not provided sufficient improvement in moderate to severe stress urinary incontinence.

NICE recommends discussing the benefits and limitations of duloxetine with the patient, including the high incidence of early nausea and the need for gradual discontinuation.

The standard NHS prescription charge in England is 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Sources

• Yentreve 40 mg, Summary of Product Characteristics (EMC)
• Duloxetine, British National Formulary (BNF)
• NICE NG123: Urinary incontinence and pelvic organ prolapse in women
• Urinary incontinence in women, NICE CKS
• Urinary incontinence, NHS
• MHRA Yellow Card Scheme